By most accounts, EU legislators will reach a compromise agreement on the proposed new Clinical Trials Regulation in time for Christmas. The key focus for industry bodies is around making sure the legislation embraces aggressive timelines for the approval of clinical trials.

Remind me, isn’t there a well-known saying about ‘haste’ and ‘speed?’

Anyway, I am afraid industry interests dominate the corridors and bars of Brussels and most of the self-proclaimed ‘patient-groups’ lobbying on this legislation bought into the corporatisation of clinical research long ago. So, what we have had is lots of industry positioning coolly argued as meeting ‘patient need,’ but very little acknowledgement of patient rights.

Last week the industry-backed European Federation for Good Clinical Practice (EFGCP) sent out their report of the ‘Multi-Stakeholder Roundtable Meeting on Sharing Clinical Trial Data in the Interest of Patients and Research’ which they hosted in October. I was struck by this quote from the report:

“One – perhaps unexpected – outcome was a focus on the participants in clinical trials. “We have to do a lot more to get back to individual patients involved in clinical trials,” said Ingrid Klingmann (EFGCP). “We owe that to patients for their willingness to contribute to the trial. At present that concept is not embedded in the proposed Regulation – but as a fundamental right it should be.”

Perhaps it was unexpected because there hasn’t been any meaningful dialogue with patients about what they want from clinical trials. And I don’t just mean about the outcome of such research, but how people would like these studies to be conducted.

Question is….have EFGCP and others listened to the patient voice? And, if they have, whether we can expect them to urge for the legislation to embrace the right of people to receive the results of trials they have been part of and for all studies to involve patients and the public to be involved in their design.

2 thoughts on “Big month in Brussels for clinical trials…but let’s not be hasty”

Thanks for posting this, Simon. Interesting as always, even when I’m not sure I agree with you! A couple thought/questions:

– I’m a little curious your use of the phrase “self-proclaimed ‘patient groups’”. Since patient groups are created for patients, they are pretty much all “self-proclaimed”, aren’t they? The thought that you might be suggesting some sort of governmental authorization for use of that designation is a little alarming – we don’t want the patients themselves making that decision?

– You mention that most of these groups have “bought in to the corporatisation of clinical research long ago”. Are you suggesting that patient groups should avoid engaging with corporate research sponsors? Given the number of potential future medicines that are or will be going through industry funded trials, that seems unwise. Many patient advocacy groups have begun to make a dramatic impact on private research priorities and trial design. The Cystic Fibrosis Foundation is one shining example of a ‘self-proclaimed’ patient group that has been extremely successful at engaging with industry to advance the science. Many rare disease advocates are increasing, not reducing, their engagement with corporations, and there are many reasons to believe that louder patient voices will have a beneficial effect on pharmaceutical company development.

I’m not suggesting Pharma’s interests are always in line with patient interests (and in light of recent leaked memos, I absolutely sympathize with a fair degree of skepticism regarding industry/patient interactions). However, the best path forward seems to me to be more, not less, patient group engagement in both public and private research.

Hi Paul,
Really appreciate you posting a comment and also the fact that you read my blog.
Both your points are good ones. I think the issue I have on the first is that the EFGCP or a UK organisation like Empower like to be seen as patient groups and yet they are, at best, a coalition of interests or, at worst, dominated by interests other than patients. That doesn’t seem quite right to me.
With regard to the second, I absolutely agree that open and honest collaboration with pharma is essential to producing new treatments.

But, given the undoubted influence of our charities and their championing of patient need, it is disappointing is it not that they don’t make patient rights a pre-requisite of their support for things like a better Clinical Trials Regulation?

Introducing requirements that patients and the public should be involved in the design of all clinical trials, or that they should receive the results of research is not going to slow research down.

Thanks for visiting my blog. I am the Executive Director at the Academy of Medical Sciences. NIHR National Director for Patients, Carers and the Public based at UCL. I was the NIHR National Director for Patients, Carers and the Public and Chair of INVOLVE from 2012 to 2019 and, before that, was the CEO of AMRC. I was awarded the OBE in the Queens Birthday Honours list in 2018. You can find out more about me on my bio available from the menu. The views expressed on this blog are my own.